FDA Product Code NVP: Holding Chambers, Direct Patient Interface
Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles
Leading manufacturers include Thayer Medical Corporation and Trudell Medical International.
FDA 510(k) Cleared Holding Chambers, Direct Patient Interface Devices (Product Code NVP)
About Product Code NVP - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code NVP since 2005, with 16 receiving FDA clearance (average review time: 247 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NVP have taken an average of 132 days to reach a decision - down from 255 days historically, suggesting improved FDA processing for this classification.
NVP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →